Senior Manager/ Manager, Quality Control (Drug Product Sterile Filling)

Company Background

Tessa Therapeutics is a clinical-stage biotechnology company focused on the development of cell therapies for a broad range of cancers.

Tessa’s clinical pipeline derives from  two innovative cell therapy platforms; CD30 Chimeric Antigen Receptors (CD30-CARs) and Virus-Specific T cells (VSTs). Our lead candidate comprises autologous CD30 CAR-T cell therapy targeting classical Hodgkin lymphoma (cHL) and CD30+ non-Hodgkin lymphomas.

Tessa is also developing a novel, allogeneic platform technology, as a new approach to traditional cell therapy. By combining the unique properties CD30-CARs and VSTs, the platform holds potential for the creation of next-generation off-the-shelf cell therapies against a variety of hematologic malignancies and solid tumors.

Tessa’s state-of-the-art GMP cell therapy manufacturing facility will open in early 2021, and will substantially enhance in-house production capabilities. Tessa is focused on rapidly and reliably providing safe, effective treatment options for patients.

Job Position
Senior Manager/ Manager, Quality Control (Drug Product Sterile Filling)

Responsibilities

  • Responsible for leading, coordinating and managing all activities associated with QC testing and release during the routine phase
  • Ensure all QC test methods are being transferred and qualified/validated prior to being used to support clinical and commercial manufacturing
  • Responsible in ensuring that the EM Program in the sterile fill/finish facility is being implemented as per plan
  • Responsible in ensuring that the EM trend reports are being developed and the trend information is being shared with the site Quality team; any adverse trends are being escalated appropriately
  • Responsible for reviewing QC test reports, test protocols and other associated documents for the sterile fill/finish facility
  • Ensure timely completion of assigned activities which include testing, method qualification/validation, equipment qualification or computer systems validation as per lead-time/milestones
  • Prepare/review/approve procedures, documents, records, deviations, investigations, corrective action/preventive actions, changes controls and gaps assessment associated with the QC area(s) assigned
  • Ensure QC personnel are qualified and trained to perform assigned tasks
  • Ensure products are tested and assessed per applicable current regulations
  • Ensure that facilities, equipment, materials, processes and procedures that are applicable to QC comply to current GMP and regulatory requirements
  • Develop and monitor team performance measures to understand effectiveness, efficiency, and quality of group performance
  • Identify, develop, track performance metrics to effectively monitor laboratory performance and customer support
  • Monitor and evaluate current regulatory requirements, making recommendations for improvements when necessary

Requirements

  • Bachelor’s Degree in Life Science discipline or any related field with at least 5 years of relevant working experience in a highly regulated cGMP regulated environment (Biologics and Pharmaceuticals etc)
  • At least 2 years of supervisory experience
  • Good understanding of current regulatory requirements of Biologics and Pharmaceutical Manufacturing
  • Experience in the areas of aseptic cGMP manufacturing, especially in Biologics or Vaccines Industry
  • Demonstrate strong leadership, good communication and organizational skills
  • Ability to prioritize work and multitask
  • Demonstrated ability to supervise, train, and manage technical staff
  • cGMP audit experience in USFDA, EU and HSA etc